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ISRCTN
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ISRCTN46178175
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ClinicalTrials.gov identifier
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Public title
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Controlled Antenatal Thyroid Screening study
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Scientific title
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Randomised controlled trial of the effect of gestational thyroid hormone intervention therapy on childhood development
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Acronym
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CATS
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Serial number at source
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065143
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Study hypothesis
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Aim is to evaluate strategy of screening of thyroid function in early pregnancy.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Trent Multi-Centre Research Ethics Committee gave approval on the 24th June 2004 (ref: MREC/04/4/026)
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Study design
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Multicentre, randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Childhood Development
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Participants - inclusion criteria
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All pregnant women (aged 18 - 45 years) before 16 weeks gestation
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Participants - exclusion criteria
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1. Twin pregnancy
2. Thyroid treatment (T4 or antithyroid drugs)
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Anticipated start date
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01/06/2002
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Anticipated end date
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01/06/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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22,000 - recruitment closed on 31st May 2006
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Interventions
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Please note that, as of 18 January 2007, this trial is closed to recruitment: follow up continuing
Sera obtained from pregnant women before 16 weeks gestation. Sera randomised to 'screen' (T4 and Thyroid Stimulating Hormones [TSH] measured at time of randomisation) and 'control' (hormones measured post delivery) groups. Thyroxine intervention given to screen group with low T4/high TSH and to control group postpartum.
This is the only prospective randomised intervention trial of thyroxine in early pregnancy.
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Primary outcome measure(s)
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Intelligence Quotient (IQ) of children in screen and control groups.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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The Wellcome Trust (UK) (grant ref: GRO65143MA)
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Trial website
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Publications
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Contact name
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Prof
John H
Lazarus
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Address
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Cardiff University
University Hospital of Wales
Professor of Clinical Endocrinology/
Heath Park
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City/town
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Cardiff
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Zip/Postcode
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CF14 4XN
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Country
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United Kingdom
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Tel
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+44 (0)29 20 742193
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Fax
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+44 (0)29 20 742193
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Email
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Lazarus@cf.ac.uk
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Sponsor
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Cardiff University (UK)
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Address
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McKenzie House
Physical and Financial Resources
30-36 Newport Road
PO Box 497
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City/town
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Cardiff
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Zip/Postcode
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CF10 3XR
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Country
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United Kingdom
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Tel
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+44 (0)29 2087 9255
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Email
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Arnoldc1@cardiff.ac.uk
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Sponsor website:
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http://www.cardiff.ac.uk/index.html
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Date applied
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22/07/2005
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Last edited
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12/09/2011
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Date ISRCTN assigned
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22/07/2005
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